Cleared Traditional

K894953 - GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS

K894953 is the FDA 510(k) clearance for GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS by Confi-Dental Products Co.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K894953 · Confi-Dental Products Co. · Dental device
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Feb 1990
Decision
186d
Days
Class 2
Risk

K894953 is an FDA 510(k) clearance for the GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on February 6, 1990 after a review of 186 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Confi-Dental Products Co. devices

Submission Details

510(k) Number K894953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1989
Decision Date February 06, 1990
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 284
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K894953.
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
KETAC-CEM MAXICAP
K897188 · Espe GmbH (Us) · Mar 1990
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · Confi-Dental Products Co. · Feb 1990
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990
KULZER GLAS-IONOMER CEMENT
K892453 · Kulzer, Inc. · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989